Taytulla – Birth Control Pill Recall

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules.
 
Allergan issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6×28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules.

Incorrectly Packaged TAYTULLA

As a result of this packaging error, oral contraceptive capsules, that are taken out of sequence, may place the user at risk for contraceptive failure and unintended pregnancy. The reversing of the order may not be apparent to either new users or previous users of the product, increasing the likelihood of taking the capsules out of order. If patients have concerns regarding the possibility of an unintended pregnancy they should consult their physician.

This product is an oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives. The TAYTULLA  pill pack is a 28 count blister card that has 24 “active” pink softgel capsules (with hormones) with “WC” printed on the outer shell in white to be taken for 24 days, followed by 4 maroon softgel capsules (without hormones) also imprinted with “WC” on one side to be taken for the next four days. If you are a patient in the U.S. who has used a TAYTULLA sample pack from lot 5620706, Exp. May 2019 since August 27, 2017, and are concerned that you may be impacted by this issue, please consult with your physician. This product was distributed Nationwide to healthcare providers.

Please refer to the affected lot number as well as the pictures below of the affected product.

Allergan is notifying customers by recall letter and is arranging for return of all recalled sample pack product with the lot #5620706 Exp. May 2019. Consumers who have the sample pack product with the associated lot number should notify their physician to arrange a return.  

Consumers with questions regarding this recall can contact Allergan by phone at 800-678-1605 8am-8pm EST Monday through Friday. Consumers should contact their physician or healthcare provider if they have questions.

For more information about TAYTULLA and the full prescribing information, please visit www.taytulla.com.

Company Contact:  1-800-678-1605

Correctly Packaged TAYTULLA

Non-Essential Appointments Cancelled

Due to COVID-19, we will be reaching out to you to reschedule any non-essential appointments (re: physicals, annuals, and other well visits) until further notice.

COVID-19 is causing things to change rapidly and our operations can vary because of this. We ask for your understanding and that you check our website for the latest on operational hours and services available.

You can also call ahead if you have questions.

We are proud of our staff who are working during this time, and pledge to you our highest service possible during this pandemic.


Patient/Visitor Guideline Update

In an effort to minimize the risk of COVID-19 transmission and provide a safer environment and promote social distancing which is recommended by the CDC, we are asking that patients limit the number of people accompanying them to an appointment. No visitors (including children) will be allowed to accompany each patient unless a specific patient needs extra support. We encouraged visitors to remain closely connected to their loved ones through virtual means, including Skype, FaceTime, WhatsApp, and/or phone.

Additionally, we are respectfully asking that children not accompany any adult patients, unless there is a medical necessity. We know this may cause scheduling challenges, particularly for families with younger siblings, but we can all play a role in reducing the spread of this virus. Thank you for understanding our need to do so and for helping us keep you and our greater community healthy.

We are also asking any patients with a cough, shortness of breath or fever not to come to our facility and call ahead of time. You will be directed to another facility for evaluation.

All patients are to wash their hands before and after their visit. Hand washing, social distancing, and self-isolation are still the best ways to prevent this virus from spreading more widely.

We are committed to providing the best care to you and will continue to give you the best guidance we can.

Please monitor our COVID-19 updates by clicking here. 

website logo